FSP-Senior Bioanalytical Study Manager

Job Title: FSP-Senior Bioanalytical Study Manager

Job Location: Remote, North Carolina, USA

Job Location Type: Remote

Job Contract Type: Full-time

Job Seniority Level:

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as a Senior Project Manager - Labs – Make an Impact at the Forefront of Innovation

The Senior Project Manager - Labs leads and has direct oversight for a portfolio of projects for a specific client and is accountable for overall project/portfolio performance. Proactively identifies resources, budgets projects, prioritizes client's portfolio in line with site-wide portfolio of projects and is the primary operational interface between PPD and the client. Negotiates and makes real-time decisions with the client. Provides internal consulting on project management issues and identifies opportunities for process and efficiency improvement. Acts as chief liaison to the operational personnel of major clients and is responsible for large study programs.

We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

What You'll Do:

• Provide oversight and coordination of client portfolio. Provide oversight to internal departments and external clients to ensure the project requirements are understood, agreed and followed at all times, requiring negotiating and real-time decision making with the client. Facilitate the flow of technical and clinical laboratory information to all stakeholders (investigational sites, sponsors, and non-technical personnel). Consult and utilize, where appropriate, the scientific input of laboratory management and technical staff to assist the client with management of the project.
  • Prepare the project specification documents and follow their preparation according to budgets and contracts. Maintain at all times an updated project master file with version controls for specifications, budgets, and contracts. Ensure sponsors have authorized and signed off the most recent versions of all documents and that a contract exists prior to delivering any services. Assure compliance with FDA and Good Clinical Practice guidelines as appropriate, PPD SOPs, personnel policies and procedures, PPD Exposure Control Plan, and applicable regulations regarding the transport of biological specimens.
  • During initial review of project documentation, consult with internal groups and support staff regarding procedural and budgetary items and the necessity for changes due to any subsequent project documentation amendments. Obtain other functions' commitment to close gaps and address issues timely and effectively. Serve as chief liaison between sponsor and all PPD internal departments performing the required tasks during all project phases. Control, manage, and follow day-to-day activities during the course of the project to resolve any issues and answer queries.
  • Actively consult with IT and data management development groups in the design, validation, and implementation of new software and functionalities pertinent to project management activities.
  • Consult with BD and finance staff during initial project documentation review on standard services and costs, support RFP feasibility assessments, advise on possible solutions if needed, and draft responses for proposals.
  • Take responsibility for accurate invoicing and coordinate with AD of finance for all billing/invoicing for the client's portfolio of projects.
  
  Education and Experience Requirements:
  • Bachelor's degree or equivalent and relevant formal academic / vocational qualification
  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years’) or equivalent combination of education, training, & experience.
  
  Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.
  
  Knowledge, Skills, Abilities:
  • Strong science and/or business acumen
  • Strong verbal, written and presentation skills
  • Superior time management, planning, and organizational skills
  • Proven analytical skills
  • Demonstrated compliance with procedures and policies
  • Ability to perform multiple tasks effectively in a stressful environment
  • Extensive knowledge and experience in Project Management
  • Strong client relationship management skills
  • Ability to work effectively with multi-level teams
  • Ability to work in a fast-paced undefined environment
  • Strong negotiation skills
  
  Working Environment:
  Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
  
  • Work is performed in a laboratory and/or a clinical environment with exposure to electrical office equipment.
  • Occasional drives to site locations, occasional domestic travel.
  • Exposure to biological fluids with potential exposure to infectious organisms.
  • Rare exposure to skin and lung irritants, radiation, toxic materials and hazardous waste.
  • Personal protective equipment required such as protective eyewear, garments and gloves.
  • Exposure to fluctuating and/or extreme temperatures on rare occasions.
  
  Why join us?
  When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.
  
  Apply today to help us deliver tomorrow’s breakthroughs.
  
  
  

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